Ultralente insulin

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Ultralente insulin was a long-acting form of insulin. It has an onset of 4 to 6 hours, a peak of 14 to 24 hours, and a duration of 28 to 36 hours. [1] Ultralente insulin, along with lente insulin, were discontinued in the US by manufacturers in the mid-2000s. One of the reasons for discontinuation was declining use in favor of NPH insulin and other newer insulin products. [2] The FDA withdrew approval for ultralente insulin products by 2011. [3]

Contents

History

Insulin which was extracted from animal sources was used as a medicine as early as 1922. [4] These early insulin preparations required multiple daily injections due to the short duration of action and quick degradation of the insulin protein. For this reason, researchers began studying how to prolong the effects of injected insulin. In 1952, a team at Novo Terapeutisk led by K. Hallas-Møller discovered that crystals of various sizes would form when zinc was added to insulin suspensions. [5] Larger insulin crystals take longer to dissolve into the bloodstream when injected into the body, and as such have a much longer duration of action than amorphous or small insulin crystals. Ultralente insulin was considered to be a "long-acting" insulin that could be used once per day to provide a basal level of insulin, similar to some protamine-containing preparations. [6]

While originally isolated from bovine or porcine sources, the advent of recombinant DNA technology in the 1980s allowed human insulin to be mass produced in yeast or bacteria. [7] By the mid 1990s, ultralente insulin was being prepared from recombinant human insulin, instead of insulin extracted from animals. [8] The advent of insulin analogues and continued use of NPH insulin led to the discontinuation of ultralente insulin products in the mid-2000s, and FDA approval to be marketed in the US was withdrawn by 2011. [2] [9] [10]

Lente insulin was a combination of ultralente insulin and amorphous, or plain, insulin in a fixed percentage combination. Ultralente insulin comprises 65% of the lente insulin preparation Vetsulin®/Caninsulin® which is produced by Merck Animal Health for veterinary use. [11]

Adverse effects

Hypoglycemia

The primary adverse effect of any insulin product is hypoglycemia, or low blood sugar. Hypoglycemia can manifest as dizziness, disorientation, trouble speaking, and changes in mental status. In severe cases, hypoglycemia can lead to loss of consciousness if not treated. [12] As lente insulin continues to be absorbed in the body for hours after use, these signs and symptoms may be delayed from the time of administration and begin with little or no warning.[ citation needed ]

Hypersensitivity

Lente insulin is a combination of porcine and bovine insulin products which are filtered and combined with zinc to form the suspension. Even product that is filtered very well is still of animal origin, and there is a chance the body may recognize the foreign protein as such and form antibodies against it. These reactions are slightly more likely with lente insulin than with insulin derived from a single source as lente insulin contains bovine insulin which is more immunogenic than porcine insulin. [13]

Society and culture

Historical brand names of ultralente insulin, all of which are now discontinued, included Ultratard HM, [14] Humulin U, and Novolin U.

Related Research Articles

Drugs used in diabetes treat diabetes mellitus by altering the glucose level in the blood. With the exceptions of insulin, most GLP receptor agonists, and pramlintide, all are administered orally and are thus also called oral hypoglycemic agents or oral antihyperglycemic agents. There are different classes of anti-diabetic drugs, and their selection depends on the nature of the diabetes, age and situation of the person, as well as other factors.

Bovine somatotropin Peptide hormone produced by cows pituitary glands

Bovine somatotropin or bovine somatotrophin, or bovine growth hormone (BGH), is a peptide hormone produced by cows' pituitary glands.

Diabetes mellitus is a chronic disease in cats whereby either insufficient insulin response or insulin resistance leads to persistently high blood glucose concentrations. Diabetes affects up to 1 in 230 cats, and may be becoming increasingly common. Diabetes mellitus is less common in cats than in dogs. Eighty to ninety-five percent of diabetic cats experience something similar to type 2 diabetes but are generally severely insulin dependent by the time symptoms are diagnosed. The condition is treatable, and if treated properly the cat can experience a normal life expectancy. In type 2 cats, prompt effective treatment may lead to diabetic remission, in which the cat no longer needs injected insulin. Untreated, the condition leads to increasingly weak legs in cats and eventually to malnutrition, ketoacidosis and/or dehydration, and death.

Insulin glargine Long-acting insulin

Insulin glargine [GLAR geen], sold under the brand name Lantus among others, is a long-acting insulin, used in the management of type I and type II diabetes. It is typically the recommended long acting insulin in the United Kingdom. It is used once a day as an injection just under the skin. Effects generally begin an hour after use.

Type 1 diabetes Form of diabetes mellitus

Type 1 diabetes (T1D), formerly known as juvenile diabetes, is an autoimmune disease that originates when very little or no insulin is produced by the islets of Langerhans in the pancreas. Insulin is a hormone required for the cells to use blood sugar for energy and it helps regulate normal glucose levels in the bloodstream. Before treatment this results in high blood sugar levels in the body. The common symptoms of this elevated blood sugar are frequent urination, increased thirst, increased hunger, weight loss, and other serious complications. Additional symptoms may include blurry vision, tiredness, and slow wound healing. Symptoms typically develop over a short period of time, often a matter of weeks.

The term diabetes includes several different metabolic disorders that all, if left untreated, result in abnormally high concentration of a sugar called glucose in the blood. Diabetes mellitus type 1 results when the pancreas no longer produces significant amounts of the hormone insulin, usually owing to the autoimmune destruction of the insulin-producing beta cells of the pancreas. Diabetes mellitus type 2, in contrast, is now thought to result from autoimmune attacks on the pancreas and/or insulin resistance. The pancreas of a person with type 2 diabetes may be producing normal or even abnormally large amounts of insulin. Other forms of diabetes mellitus, such as the various forms of maturity onset diabetes of the young, may represent some combination of insufficient insulin production and insulin resistance. Some degree of insulin resistance may also be present in a person with type 1 diabetes.

An insulin analog is any of several types of insulin (medication) that are altered forms of the hormone insulin, different from any occurring in nature, but still available to the human body for performing the same action as human insulin in terms of controlling blood glucose levels in diabetes. Through genetic engineering of the underlying DNA, the amino acid sequence of insulin can be changed to alter its ADME characteristics. Officially, the U.S. Food and Drug Administration (FDA) refers to these agents as insulin receptor ligands, although they are usually just referred to as insulin analogs.

NPH insulin Intermediate acting insulin formulation

Neutral Protamine Hagedorn (NPH) insulin, also known as isophane insulin, is an intermediate-acting insulin given to help control blood sugar levels in people with diabetes. It is used by injection under the skin once to twice a day. Onset of effects is typically in 90 minutes and they last for 24 hours. Versions are available that come premixed with a short-acting insulin, such as regular insulin.

Exenatide Medication

Exenatide, sold under the brand name Byetta and Bydureon among others, is a medication used to treat diabetes mellitus type 2. It is used together with diet, exercise, and potentially other antidiabetic medication. It is a treatment option after metformin and sulfonylureas. It is given by injection under the skin within an hour before the first and last meal of the day. A once-weekly injection version is also available.

Inhalable insulin is a powdered form of insulin, delivered with an inhaler into the lungs where it is absorbed. In general inhaled insulins have been more rapidly absorbed than subcutaneous injected insulin, with faster peak concentration in serum and more rapid metabolism.

Sitagliptin Diabetes medication

Sitagliptin, sold under the brand name Januvia among others, is an anti-diabetic medication used to treat type 2 diabetes. In the United Kingdom it is listed as less preferred than metformin or a sulfonylurea. It is taken by mouth. It is also available in the fixed-dose combination medication sitagliptin/metformin.

Muraglitazar

Muraglitazar is a dual peroxisome proliferator-activated receptor agonist with affinity to PPARα and PPARγ.

Regular insulin Short-acting insulin formulation

Regular insulin, also known as neutral insulin and soluble insulin, is a type of short-acting insulin. It is used to treat type 1 diabetes, type 2 diabetes, gestational diabetes, and complications of diabetes such as diabetic ketoacidosis and hyperosmolar hyperglycemic states. It is also used along with glucose to treat high blood potassium levels. Typically it is given by injection under the skin, but may also be used by injection into a vein or muscle. Onset of effect is typically in 30 minutes and it typically lasts for 8 hours.

Insulin (medication) Use of insulin protein and analogs as medical treatment

As a medication, insulin is any pharmaceutical preparation of the protein hormone insulin that is used to treat high blood glucose. Such conditions include type 1 diabetes, type 2 diabetes, gestational diabetes, and complications of diabetes such as diabetic ketoacidosis and hyperosmolar hyperglycemic states. Insulin is also used along with glucose to treat hyperkalemia. Typically it is given by injection under the skin, but some forms may also be used by injection into a vein or muscle. There are various types of insulin, suitable for various time spans. The types are often all called insulin in the broad sense, although in a more precise sense, insulin is identical to the naturally occurring molecule whereas insulin analogues have slightly different molecules that allow for modified time of action. It is on the World Health Organization's List of Essential Medicines. In 2019, regular human insulin was the 298th most commonly prescribed medication in the United States, with more than 1 million prescriptions.

Minimed Paradigm Insulin pumps

MiniMed Paradigm is a series of insulin pumps manufactured by Medtronic for patients with diabetes mellitus. The pump operates with a single AAA battery and uses a piston-plunger pump to infuse a programmed amount of insulin into the patient through a length of tubing. The Paradigm uses a one-way wireless radio frequency link to receive blood sugar measurements from select glucose meters. The Paradigm RT series adds the ability to receive data from a mated continuous blood-glucose monitor. Although the pump can use these measurements to assist in calculating a dose of insulin, no actual change in insulin delivery occurs without manual user-intervention.

Diabetes in dogs

Diabetes mellitus is a disease in which the beta cells of the endocrine pancreas either stop producing insulin or can no longer produce it in enough quantity for the body's needs.

Lente insulin Historical formulation of insulin as medication

Lente insulin was an intermediate duration insulin that is no longer used in humans. The onset of lente insulin is one to two hours after the dose is administered, and the peak effect is approximately 8 to 12 hours after administration, with some effects lasting over 24 hours.

Insulin degludec Ultralong-acting basal insulin analogue

Insulin degludec (INN/USAN) is an ultralong-acting basal insulin analogue that was developed by Novo Nordisk under the brand name Tresiba. It is administered via subcutaneous injection once daily to help control the blood sugar level of those with diabetes. It has a duration of action that lasts up to 42 hours, making it a once-daily basal insulin, that is one that provides a base insulin level, as opposed to the fast- and short-acting bolus insulins.

Glucommander is a computer-directed method of inpatient glucose management.

Chromium is claimed to be an essential element involved in the regulation of blood glucose levels within the body. More recent reviews have questioned this however.

References

  1. ↑ Gomella LG, Haist SA. Chapter 22. Commonly Used Medications. In: Gomella LG, Haist SA, eds. Clinician's Pocket Reference: The Scut Monkey. 11th ed. New York: McGraw-Hill; 2007. http://www.accessmedicine.com/content.aspx?aID=2696124. Accessed February 4, 2012
  2. 1 2 Discontinuation of Humulin®U ULTRALENTE at the Wayback Machine (archived 1 December 2011)
  3. ↑ "List of Withdrawn Applications for Biological Products That Were Removed From FDA's Orange Book on March 23, 2020". fda.gov. US Food and Drug Administration. Retrieved 18 May 2020.
  4. ↑ Quianzon, Celeste C.; Cheikh, Issam (16 July 2012). "History of insulin". Journal of Community Hospital Internal Medicine Perspectives. 2 (2): 18701. doi: 10.3402/jchimp.v2i2.18701 . PMC   3714061 . PMID   23882369.
  5. ↑ Hallas-Moller, K.; Petersen, K.; Schlichtkrull, J. (10 October 1952). "Crystalline and Amorphous Insulin-Zinc Compounds with Prolonged Action". Science. 116 (3015): 394–398. Bibcode:1952Sci...116..394H. doi:10.1126/science.116.3015.394. PMID   12984132.
  6. ↑ Hallas-Mo, K. (1 January 1956). "The Lente Insulins". Diabetes. 5 (1): 7–14. doi:10.2337/diab.5.1.7. PMID   13294001. S2CID   84960159.
  7. ↑ Ladisch, Michael R.; Kohlmann, Karen L. (November 1992). "Recombinant human insulin". Biotechnology Progress. 8 (6): 469–478. doi:10.1021/bp00018a001. PMID   1369033. S2CID   11674368.
  8. ↑ Riccio, A.; Avogaro, A.; Valerio, A.; Zappella, A.; Tiengo, A.; Prato, S. D. (1 June 1994). "Improvement of Basal Hepatic Glucose Production ana Fasting Hyperglycemia of Type I Diabetic Patients Treated With Human Recombinant Ultralente Insulin". Diabetes Care. 17 (6): 535–540. doi:10.2337/diacare.17.6.535. PMID   8082521. S2CID   39297137.
  9. ↑ Federal Register Doc. E9-2901
  10. ↑ Federal Register Doc. 2011-14164
  11. ↑ "Vetsulin Insulin for Pets". www.merck-animal-health-usa.com. Merck Animal Health USA. Retrieved 18 May 2020.
  12. ↑ "Hypoglycemia". National Institute of Diabetes and Digestive and Kidney Diseases. October 2008. Archived from the original on 1 July 2015.
  13. ↑ Deckert, T. (1 September 1980). "Intermediate-acting Insulin Preparations: NPH and Lente". Diabetes Care. 3 (5): 623–626. doi:10.2337/diacare.3.5.623. PMID   7192205. S2CID   22310080.
  14. ↑ Holman, R R; Steemson, J; Darling, P; Reeves, W G; Turner, R C (3 March 1984). "Human ultralente insulin". BMJ. 288 (6418): 665–668. doi: 10.1136/bmj.288.6418.665 . PMC   1444374 . PMID   6421424.
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